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2019 PartInject

Mastering Automated Visual Inspection - Fall Edition

Sep 26 - Sep 27, 2019
Berlin, Germany

This new advanced training course has been devised to support the participant to develop his own Automated Visual Inspection program. Prerequisite for the course is basic understanding and practical experience of manual inspection and/or the participation in the PDA Europe course ‘Introduction to Visual Inspection.

  • Education
  • Europe
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Program Highlights

Overview

Visual Inspection mastery is fundamental in parenteral manufacturing in order to guarantee both patient safety and cost effective supply. The capability of Automated Visual Inspection (AVI) has progressed extensively over the years to the point where, when applied appropriately, it can offer significant advantages over manual and semi-automated inspection processes. This has been made possible thanks to major innovations and technology breakthroughs. In line with these technological advances, the regulatory requirements for this challenging process have been reinforced. As a consequence, AVI machines today are complex and require multidisciplinary project teams for successful implementation and to manage continous improvement.

This course has been devised to support your AVI program development, by addressing critical parameters, key competencies and practical approaches to managing the inherent complexity of AVI. In day 1, after a review of regulatory landscape, key functions of AVI equipment and associated critical parameters will be covered. Then, the participants will look at the interaction between primary packaging component and AVI of the filled drug product. Successful URS development will be covered by a practical workshop in order to address not only user needs but also to produce a comprehensive process flow model. In Day 2, the need for an effective Manual Visual Inspection (MVI) baseline process will be overviewed as a prerequisite to AVI. Then, defect kits and validation strategies will be described. AVI has a scope broader than computer vision alone and the overall control strategy for the process will be covered. ‘Vision Engineering for dummies’ will be explained during a practical workshop using modern vision equipment and genuine examples of production defects

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Agenda

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  • Day 1
  • Day 2

  • Thursday, 26 September 2019

    9:00
    Welcome & Introduction

    9:30
    Theory 1: Introduction Into Regulatory Requirements of Visual Inspection

    • USP 1, USP 788 and 1788, USP 790 and 1790
    • PhEur e.g. 2.9.20 • JP e.g. 6.06
    • Annex 1
    • Similarities and differences in compendial methods
    • 100% inspection and AQL testing
    • Definitions and practical examples of inherent, intrinsic and extrinsic particles
    10:45
    Coffee Break

    11:15
    Theory 2: Introduction Into Technical Principles of Automated Inspection Machines

    • Functionality of automated inspection machines
    • Camera systems / light / motion
    • Image processing and database system
    • Interlinkage of parameters: Speed, Rotation speed, Inspection parameters, Detection probability, False reject rate
    • Properties, capabilities and limitations of automated inspection systems
    • Scope of Automated Visual Inspection
    12:15
    Lunch Break

    13:15
    Theory 2: Introduction Into Technical Principles of Automated Inspection Machines (cont.)

    14:15
    Theory 3: Considerations on Primary Containers and Product Properties

    • Vials, Ampoules, Syringes, Blow – Fill - Seal, Viscous liquids, Air bubbles / scratches, Refrigerated product containers

    14:45
    Exercise 1: Developing an URS Considering the Triangle Cost / Quality / Time

    15:45
    Coffee Break

    16:15
    Theory 4: Selection and Purchasing of an Automated Inspection System

    • Technical requirements
    • Integration into existing processes, lines/ machines and systems
    • Cost and effort considerations
    • Risk Assessment

    17:15
    Exercise 1 (cont.): Presentation of the Results of the Sub-Groups and Discussion of the Results

    Q & A
    17:15

    End of Day 1

  • Friday, 27 September 2019

    9:00
    Recap of Day 1

    9:15
    Theory 5: Transition from Manual Inspection to Automated Inspection

    • Manual inspection as a prerequisite for transition to automated inspection
    • Interpretation of inspection results and validation data
    • Considerations on validation program for automated inspection
    • Performance measurement
    • Maintaining the manual inspection

    10:15
    Exercise 2: Principle Basic Image Processing Using an Open Source Library

    11:00
    Coffee Break

    11:15
    Exercise 2 (cont.): Presentation of the Results

    12:00
    Theory 6: Qualification Test Set and Routine Test Set

    • Statistical considerations on number of objects containing defects
    • Particle selection, particle size and size uniformity
    • Labelling of test set objects
    • Supply/purchase of test sets
    • Maintaining and lifecycle of test sets
    • Sampling from rejects
    • Defect master library
    • Types of defects
    • Quality requirements
    13:00
    Lunch Break

    14:00
    Theory 7: Visual Inspection Lifecycle and Control Strategy

    • Integration of visual inspection into overall manufacturing process
    • Elements of lifecycle
    • Particle identification/characterization
    • Defect libraries as dynamic database
    • AQL and control charting

    15:00
    Theory 8: Operation and Maintenance of Automated Inspection Systems

    15:30
    Coffee Break

    16:00
    Future Trend of Automated Visual Inspection

    16:30
    End of Training Course

Trainers

Sébastien Koch
Sébastien Koch
Merck Switzerland
Bio
Sébastien Koch
Merck Switzerland

Sébastien has over 18 years field experience in visual Inspection. In 2000 he began his career for Eli Lilly as specialist in Vision technology to carry out Automated Visual Inspection Machines (AVIM) qualification, maintenance and continuous improvement. In 2010, as Green Belt Six Sigma Sébastien became lean manufacturing engineer to drive operational excellence. In 2012, he took over the lead as Responsible Engineer.

In 2016, Sébastien joined Merck in Switzerland to support the Aubonne site development as a driver of change and progress. Responsible of the visual Inspection equipment, he leads the strategic roadmap for long term perspectives, the validation strategy and the permanent competitiveness improvements of the manufacturing processes for quality and cost efficiency.
Fernand Koert
Fernand Koert
Dresden GlaxoSmithKline Vaccines
Bio
Fernand Koert
Dresden GlaxoSmithKline Vaccines

Fernand was born in the Hague, Netherlands and started his academic career at the Technical University of Delft to study Electronics. Working in that field, he completed career stages from shift leader to assistant plant manager. After gaining extensive practical experience, he started studying Process Technology at the Maritime Faculty in Amsterdam, graduating Cum Laude and working as a process engineer there after. In 2000, Fernand became a freelancer helping companies to set up practical training programs for operators. At Teva Pharmaceuticals, he did the same and became head of the packaging department in 2003. In 2005, he returned to technical engineering by assuming responsibility for reshaping and automation of packaging lines. Since 2011, Fernand has been specializing in vision technology, improving and sampling for test kits and validation. In 2014, he started with GSK, developing recipes for Seidenader AVI, first in Belgium, and currently for GSK in Dresden, Germany.

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this course, you will be able to:
    • Acquire basics about Regulatory landscape for AVI
    • Be ready to design your URS
    • Understand Key function of AVI equipment
    • Define your defect kits and validation strategy
    • Develop your own control strategy around AVI
    • Test normallity at a glance, interpret, and communicate the results.
    • Have basic knowledge about computer vision
  • Who Should Attend

    Who Should Attend

    This course is designed specifically for those who are involved or interested in moving from manual to automated inspection like

    • Managers, Supervisors and all Decision makers in the visual inspection area
    • Quality personnel
    • Prerequisites: Basic understanding and practical experience of manual inspection (as conveyed in the PDA course ‘Introduction to Visual Inspection’)
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Berlin Marriott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany
Phone: +49 (0)30-220000

Berlin Marriott Hotel
  • Accommodations

    Hotel Website

    Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

    Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

    Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

    PDA Europe has reserved a limited number of rooms until the 26th July 2019.
    Book Your Room for the PDA Group Rate

    Single Room € 195 per night*
    Double Room € 215 per night*

    *Rates are per room and night, including the following services and benefits:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
5.6 mi (9 km), 18 min by car
Alternate transportation: Limousinen Service; fee: 100 EUR (one way); reservation required
Estimated taxi fare: 25 EUR (one way)
Bus service, fee: 2.8 EUR (one way)
Subway service, fee: 2.8 EUR (one way)
Take the Bus X9 and get off at Zoologischer Garden, then take the subway U2 towards Pankow and get off at Potsdamer Platz.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
12.7 mi (20.4 km), 25 min by car
Alternate transportation: Limousinen Service; fee: 130 EUR (one way); reservation required
Estimated taxi fare: 45 EUR (one way)
Bus service, fee: 3.6 EUR (one way)
Subway service, fee: 3.6 EUR (one way)
Take the train S45 to S-Bahnhof Suedkreuz. Then change to the S-train S2 and get off at Potsdamer Platz.

By Car

The Berlin Marriott Hotel is located at Inge-Beisheim Platz 1.

Other Options

Berlin Central Station: 2.3 mi from hotel.

Train Station Berlin Friedrichstrasse: 1.1 mi from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595




* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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